[e-farmacos] Diclofenac (cont.)

["Rousseau, Marcela" <marcerousseau@hotmail.com>]

Estimada Mariana,

Segun MICROMEDEX, el diclofenac en la parte de usos  terapeuticos, veras que no tiene aprobacion para antitermico segun la  FDA, envio la cita. 

Suerte,

Marcela Rousseau
Hospital Garrahan
Farmacovigilancia
(Argentina)

FEVER
1. OVERVIEW:
FDA APPROVAL: Adult, no; pediatric, no
EFFICACY: Adult, effective; pediatric, effective
DOCUMENTATION: Adult, fair; pediatric, good

 * 2. SUMMARY:
- Diclofenac was effective in lowering temperature due  to infection in children and adults
 * 3. ADULT: 
 + a. Low dose diclofenac (0.2 milligram/kilogram) intravenously  is effective as an antipyretic. The antipyretic effect of  diclofenac sodium 0.2 milligram/kilogram intravenously given  over 5 minutes in 10 ICU patients was studied (Pesenti et al,  1986). Etiologies for fever included ARDS, multiple trauma,  and sepsis. The mean basal temperature was 38.92 degrees C  +/- 0.41. In 9 of 10 patients, the temperature fell by more  than 0.5 degrees C within 1 hour of diclofenac  administration. Maximum temperature lowering effect was  achieved after 3 hours (mean temperature 37.8 degrees C +/-  0.64). Temperatures remained below basal temperature  throughout the 6 hour observation period.

 * 4. PEDIATRIC:
 + a. For children 2 to 5 years of age, a diclofenac 25  milligram suppository effectively reduced fever; whereas, a  50 mg suppository was effective in older children. In a
 double-blind, placebo controlled, between patient trial,  diclofenac was studied in 43 children ranging in age from 2  to 10 years. All patients were hospitalized because of acute  illnesses associated with fever (38.5 to 40.4 degrees  Centigrade). Patients 2 to 5 years of age received a  diclofenac 25 mg suppository or placebo. Children age 6 to 10  received a 50 mg diclofenac suppository or placebo. Body  temperature and pulse rate were measured at the time of  administration and at one-half, one, two, four and six hours   after administration. In patients treated with diclofenac,  temperature returned to normal after 2 hours in all patients.  Very little change in temperature was seen in patients who  received placebo (Polman et al, 1981). 
 + b. Diclofenac was effective for reducing fever of infectious  origin (greater than 38.5 degrees Centigrade) in 50 children  aged 0.1 to 4.3 years. Diclofenac 0.25 to 0.5 mg/kg was  administered orally or rectally. Rectal temperatures were  taken at 7 intervals up to 8 hours post-drug. The maximal  fall of temperature was reached in 4 hours with all doses.  Suppositories were the most effective in reducing fever. No  side effects were observed in this study  (Keinanen-Kiukaannemi et al, 1980)